比美吉珠单抗可迅速改善活动性银屑病关节炎患者的患者报告症状和健康相关生活质量：两项 3 期研究的 16 周汇总结果。
Bimekizumab provided rapid improvements in patient-reported symptoms and health-related quality of life in patients with active psoriatic arthritis: pooled 16-week results from two phase 3 studies.
机构信息
Department of Rheumatic and Immunologic Diseases, Cleveland Clinic, Cleveland, Ohio, USA
Orthopedic and Rheumatologic Institute, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, Ohio, USA.
出版信息
RMD Open. 2024 Sep 23;10(3):e004464. doi: 10.1136/rmdopen-2024-004464.
OBJECTIVES
To assess impact of bimekizumab treatment on patient-reported outcomes and health-related quality of life (HRQoL) in patients with active psoriatic arthritis (PsA), using 16-week data from two phase 3 studies.
METHODS
BE OPTIMAL (NCT03895203; biologic disease-modifying antirheumatic drug (bDMARD)-naïve) and BE COMPLETE (NCT03896581; tumour necrosis factor inhibitor inadequate response/intolerance (TNFi-IR)) are phase 3 studies of subcutaneous bimekizumab 160 mg Q4W; both were double-blind and placebo-controlled to 16 weeks. Patients were randomised 3:2:1 to bimekizumab, placebo or reference (subcutaneous adalimumab 40 mg Q2W) in BE OPTIMAL; 2:1 to bimekizumab or placebo in BE COMPLETE. Patient-reported outcomes for pain, fatigue, physical function and HRQoL are reported to week 16 using pooled and individual study data for bimekizumab and placebo patients.
RESULTS
1073/1112 (96.5%) patients completed week 16 (bimekizumab: 677/698 [97.0%]; placebo: 396/414 [95.7%]). Bimekizumab-treated patients achieved rapid improvements vs placebo in pain, fatigue, physical function and HRQoL by week 4, after a single dose. Improvements continued to week 16 for all patient-reported outcomes, including Pain Visual Analogue Scale (VAS; mean (95% CI) change from baseline: bimekizumab: -25.2 [-27.2, -23.1]; placebo: -5.7 [-8.2, -3.3]) and FACIT-Fatigue (bimekizumab: 4.5 [3.9, 5.1]; placebo: 1.1 [0.3, 2.0]); both nominal p<0.001. Greater proportions of bimekizumab-treated patients achieved minimal clinically important differences for patient-reported symptoms vs placebo, including FACIT-Fatigue (bimekizumab: 53.1%; placebo: 36.3%) and HAQ-DI (bimekizumab: 53.0%; placebo: 28.7%); both nominal p<0.001.
CONCLUSION
Bimekizumab treatment demonstrated rapid and greater improvements in patient-reported pain, fatigue, physical function and HRQoL to week 16 vs placebo in bDMARD-naïve and TNFi-IR patients.
TRIAL REGISTRATION NUMBER
ClinicalTrials.gov: NCT03895203; NCT03896581.
目的
评估双美克单抗治疗对活动性银屑病关节炎（PsA）患者报告结局和健康相关生活质量（HRQoL）的影响，使用两项 3 期研究的 16 周数据。
方法
BE OPTIMAL（NCT03895203；生物制剂改善病情抗风湿药（bDMARD）初治）和 BE COMPLETE（NCT03896581；肿瘤坏死因子抑制剂反应不足/不耐受（TNFi-IR））是双美克单抗 160mg Q4W 皮下给药的 3 期研究；均为双盲安慰剂对照至 16 周。在 BE OPTIMAL 中，患者按 3:2:1 随机分配至双美克单抗、安慰剂或参考（皮下阿达木单抗 40mg Q2W）；在 BE COMPLETE 中，患者按 2:1 随机分配至双美克单抗或安慰剂。使用双美克单抗和安慰剂患者的汇总和个体研究数据，报告至第 16 周的疼痛、疲劳、身体功能和 HRQoL 的患者报告结局。
结果
1073/1112（96.5%）名患者完成第 16 周（双美克单抗：677/698 [97.0%]；安慰剂：396/414 [95.7%]）。与安慰剂相比，双美克单抗治疗的患者在第 4 周单次给药后即快速改善疼痛、疲劳、身体功能和 HRQoL，至第 16 周仍持续改善所有患者报告结局，包括疼痛视觉模拟量表（VAS；自基线的平均（95%CI）变化：双美克单抗：-25.2[-27.2，-23.1]；安慰剂：-5.7[-8.2，-3.3]）和 FACIT-Fatigue（双美克单抗：4.5[3.9，5.1]；安慰剂：1.1[0.3，2.0]）；均为名义 p<0.001。与安慰剂相比，更多的双美克单抗治疗患者达到了患者报告症状的最小临床重要差异，包括 FACIT-Fatigue（双美克单抗：53.1%；安慰剂：36.3%）和 HAQ-DI（双美克单抗：53.0%；安慰剂：28.7%）；均为名义 p<0.001。
结论
在 bDMARD 初治和 TNFi-IR 患者中，与安慰剂相比，双美克单抗治疗至第 16 周时，患者报告的疼痛、疲劳、身体功能和 HRQoL 迅速且更大程度地改善。
试验注册
ClinicalTrials.gov：NCT03895203；NCT03896581。
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